K011878 is an FDA 510(k) clearance for the EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL. This device is classified as a Colorimetry, Salicylate (Class II - Special Controls, product code DKJ).
Submitted by Syva Co. (Cupertino, US). The FDA issued a Cleared decision on August 13, 2001, 59 days after receiving the submission on June 15, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3830.
| 510(k) Number | K011878 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2001 |
| Decision Date | August 13, 2001 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DKJ — Colorimetry, Salicylate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3830 |